MAUDE Adverse Event Report: SEASPINE, INC. NEWPORT MODULAR COUNTER TORQUE

Catalog Number 91-8429

Device Problems Sticking (1597); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

It was reported that during surgery, the two newport modular counter torques 'would not slide over the extended tab screws without literally having to be hammered on.Both shafts were difficult to pass extensions through.But one was worse than the other.The surgeon (literally) had to hammer them on.' additional information was received on (b)(6) 2014.There was no delay in surgery or adverse consequence to the patient.The customer said he was most concerned that the surgeon had to use a great deal of force with the counter torque to go over the tab screws.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: NEWPORT MODULAR COUNTER TORQUE
• Type of Device: NEWPORT
• Manufacturer (Section D): SEASPINE, INC.; vista CA 92084
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3943582
• MDR Text Key: 4639606
• Report Number: 2032593-2014-00020
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 91-8429
• Device Lot Number: AU4056202B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 04/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NEWPORT DEPLOYER: 91-8431; NEWPORT MIS CAP/ROD COMBO 2: 60-0345